RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBioVentrix
About this trial
A prospective, multi-center randomized trial comparing the Revivent System plus GDMT to GDMT alone. A total of approximately 135 subjects will be randomized in a 2:1 allocation ratio (90 treatment and 45 control), with approximately 128 evaluable patients and assuming 5% loss to follow-up. A primary safety endpoint will be evaluated at 30 days. Primary efficacy endpoint will be at 1 year. Interim efficacy endpoints will be evaluated at 6 months.
Eligibility criteria
Qualifiers
18 years old or older
LV Aneurysm or Scar Presence: Defined by presence of a contiguous acontractile (akinetic and/or dyskinetic) non-calcified scar
LV Aneurysm/Scar Location: Defined as a scar involving anterior, apical or anterolateral ± septal regions of the left ventricle as evidenced by cardiac imaging (Viability of myocardium in regions remote from area of intended scar exclusion as evidenced by cardiac imaging)
Left Ventricular Ejection Fraction < 40%
Disqualifiers
Cardiac Resynchronization Therapy (CRT) or ICD pacing lead placement ≤ 90 days prior to enrollment
Valvular heart disease, which in the opinion of the investigator, will require intervention (transcatheter or surgical)
Mitral Regurgitation greater than moderate (>2+)
Need for coronary revascularization, in the opinion of the investigator
Trial design
Treatments tested in this trial
- Revivent System
Treatment groups
135 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov